Inappropriate IP administration (dose/timing dispensing error)
Inappropriate IP Administration (Dose/Timing) Dispensing Error Table
Inappropriate IP Administration (Dose/Timing) Dispensing Error
Type of indicator
Risk
Risk Category
IMP
Golden KRI
No
Therapeutic Area
General
IF Risk-Event
The study drug is not dispensed properly
DUE TO Risk Causes
Misunderstanding of the dispensing instructions or protocol, lack of clarity in instructions, poor training, or other reason
THEN Risk Impact MAY RESULT
Negative impact on subject safety, protocol deviations and challenges drawing conclusions from the trial for efficacy and/or safety
Risk Indicator
Incorrect IP administration (dose/timing dispensing error)
Metric
Percent of IMP dispensations that are incorrect
Unit
%
What level should be measured
Study, Country, Site, Subject
Purpose
Identify instances where there are deviations in IP administration that may put participant(s) at unnecessary risk and/or impact the integrity of clinical trial data.
Description
This KRI monitors the occurrence of a higher than expected proportion of occasions where investigational products are administered incorrectly.
Formula
(Number of incidents of incorrect IP administration)/(Number of IP administrations) x 100
Suggested Thresholds - High
>15 %
Suggested Thresholds - Medium
>10 %
Associated Metric 1
Number of incidents of incorrect IP administration
Associated Metric 2
Number of IP administrations
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